The device associated with this report was not returned.A complaint database search finds no other reported incidents against the provided product and lot combination.Requests for additional investigational inputs were made in accordance with (b)(4) appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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